Comparison Between The Hemodynamic Effects of Cutaneous Nitroglycerin And Intravenous Nitrogltcerin In Patients Under Phacoemulsification surgery surgery
The purpose of this study is comparison between the hemodynamic changes of skin patch of nitroglycerin and intravenous nitroglycerin in phacoemulsification surgery. This study is designed as a randomized, prospective, interventional and single blind clinical trial. The study population all the known ischemic heart patients who are candidate for phacoemulsification surgery. Inclusion criteria consist of: Phacoemulsification surgery under general anesthesia. Exclusion criteria consist of: Patients with uncontrolled type 1and type 2 diabetics ; Severe left ventricular dysfunction; patients with ASA 3 and more. In this study 50 patients are selected and 25 patients in one groups are considered. One group of patients will be received nitroglycerin skin patch up to 2 cm on the anterior chest wall 40 minutes before induction of anesthesia. Another group will be received 0.5 mcg / kg / min intravenous nitroglycerin before induction of anesthesia and the dose will be adjusted according to hemodynamic changes. Systolic blood pressure ;diastolic blood pressure; mean arterial blood pressure and heart rate will be recorded with noninvasive heart monitoring with a specified times (before induction of anesthesia ; 1 minute and 3 minutes after induction ; after placement of a laryngeal mask ; after surgical stimulation; after removal of laryngeal mask; 2 hours postoperative).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105125751N2
Registration date:2012-07-20, 1391/04/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-07-20, 1391/04/30
Registrant information
Name
Abdolrasoul Anvaripour
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1252 6801
Email address
anvari@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical sciences
Expected recruitment start date
2012-07-24, 1391/05/03
Expected recruitment end date
2012-08-25, 1391/06/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Between The Hemodynamic Effects of Cutaneous Nitroglycerin And Intravenous Nitrogltcerin In Patients Under Phacoemulsification surgery surgery
Public title
Comparison of Two Different Forms of Nitroglycerin In Anesthesia of The Patients Under Phacoemulsification Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria consist of: Known Ischemic Heart Disease Patients Candidate for Phacoemulsification Surgery
Exclusion criteria Consist of : Uncontrolled Type 1 and 2 Diabetics; Patients With Severe Left ventricular Dysfunction
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Busheh University of Medical Sciences
Street address
Pardis Site; Bahmani; Bushehr University of Medical Sciences
City
Bushehr
Postal code
Approval date
2012-05-17, 1391/02/28
Ethics committee reference number
10581
Health conditions studied
1
Description of health condition studied
Cataract
ICD-10 code
H25.9
ICD-10 code description
Senile cataract, unspecified
Primary outcomes
1
Description
Systolic Blood Pressure
Timepoint
Before Induction of anesthesia; 1 minute after induction; 3 minutes after induction; after LMA insersion; after surgical stimulation; post extubation; 2 hours postoperation
Method of measurement
Noninvasive Blood Pressure Monitoring
2
Description
Diastolic Blood Pressure
Timepoint
Before induction of anesthesia; 1 minute after induction; 3 minutes after induction; after LMA insersion; after surgical stimulation; post extubation; 2 hours postoperation
Method of measurement
Noninvasive Blood Pressure Monitoring
3
Description
Heart Rate
Timepoint
Before induction of anesthesia; 1 minute after induction; 3 minutes after induction; after LMA insersion; after surgical stimulation; post extubation; 2 hours postoperation
Method of measurement
Noninvasive Blood Pressure Monitoring
4
Description
Mean Arterial Pressure
Timepoint
Before induction of anesthesia; 1 minute after induction; 3 minutes after induction; after LMA insersion; after surgical stimulation; post extubation; 2 hours postoperation
Method of measurement
Noninvasive Blood Pressure Monitoring
Secondary outcomes
1
Description
New Changes In Electrocardiography
Timepoint
Perioperative Period; 2 hours after operation
Method of measurement
Noninvasive Blood Pressure Monitoring
Intervention groups
1
Description
In Interventional Group: Skin Patch of Nitroglycerin up to 2 cm Anterior Chest Wall 40 minutes Before Induction of Anesthesia
Category
Treatment - Drugs
2
Description
In Control Group: Intravenous Nitroglycerin 0.5 microgram/kg/minute Before Induction of anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemezahra Hospital
Full name of responsible person
Abdolrasoul anvaripour
Street address
Fatemezahra Hospital; Moalem Street
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bushehr Universiy of Medical Sciences
Full name of responsible person
Mahnoush khakzad
Street address
Pardis site; Bahmani
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bushehr Universiy of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Abdolrasoul Anvaripour
Position
Assistant Professor of Cardiac Anesthesiology
Other areas of specialty/work
Street address
Fatemezahra Hospital
City
Bushehr
Postal code
Phone
+7 712526802
Fax
Email
a.anvari.p@hotmail.com anvari@bpums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Abdolrasoul Anvaripour
Position
Assistant Professor of Cardiac Anesthesiology
Other areas of specialty/work
Street address
Fatemezahra hospital
City
Bushehr
Postal code
Phone
+98 77 1252 6802
Fax
Email
a.anvari.p@hotmail.com anvari@bpums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Abdolrasoul Anvaripour
Position
Assistant Professor of Medical Sciences
Other areas of specialty/work
Street address
Fatemezahra Hospital; Moalem Street
City
Bushehr
Postal code
Phone
+98 77 1252 6802
Fax
Email
anvari@bpums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)